Mineralys Therapeutics, Inc. (NASDAQ:MLYS) Q2 2025 Earnings Call Transcript

Mineralys Therapeutics, Inc. (NASDAQ:MLYS) Q2 2025 Earnings Call Transcript August 13, 2025

Operator: Greetings, and welcome to the Mineralys Second Quarter 2025 Earnings Call. [Operator Instructions] It is now my pleasure to introduce your host, Dan Ferry of LifeSci Advisors. Thank you. You may begin.

Daniel Ferry: Lifesci Advisors, LLC Thank you, operator. I would like to welcome everyone joining us today for our second quarter 2025 financial results and business updates. Earlier this afternoon, we issued a press release providing our second quarter 2025 financial results [Technical Difficulty] approximately 1 hour after its completion. After our prepared remarks, [Technical Difficulty] we will open the call for Q&A. Before we begin, I would like to remind everyone that this conference call [Technical Difficulty] and webcast will contain forward- looking statements about the company. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company’s business.

These forward-looking statements are qualified by the cautionary statements contained in today’s press release and our SEC filings, including our annual report on Form 10-K and subsequent filings. Please note that these forward-looking statements reflect our opinions only as of today, August 12, 2025. Except as required by law, we specifically disclaim any obligation to update or revise these forward-looking statements [Technical Difficulty] I would now like to turn the call over to Jon Congleton, Chief Executive Officer of Mineralys Therapeutics.

Jon Congleton: Thank you, Dan. Good afternoon, everyone, and welcome to our second quarter 2025 financial results and corporate update conference call. I’m joined today by Adam Levy, our Chief Financial Officer; Dr. David Rodman, our Chief Medical Officer; and Eric Warren, our Chief Commercial Officer. I will begin with an overview of the business, our clinical programs and recent milestones, followed by Adam to review our second quarter financial results before we open the call for your questions. We’re proud to be leading the way in the development of aldosterone synthase inhibitors or ASIs for the treatment of hypertension and comorbid cardiorenal conditions such as chronic kidney disease, or CKD, and obstructive sleep apnea, or OSA.

Earlier this year, we became the first company to announce pivotal data for an ASI with the readouts from Launch-HTN and Advance- HTN. These results have since been presented at leading scientific conferences and published in the New England Journal of Medicine and the Journal of the American Medical Association. The clinically meaningful and sustained reductions in systolic blood pressure demonstrated with [Technical Difficulty] underscoring the unmet need, the desire for innovation in the management of hypertension and the commercial potential of lorundrostat. To better understand how our data could translate into clinical use, we surveyed approximately 300 cardiologists and primary care physicians. The key takeaway from that survey was that 95% of these practicing clinicians indicated that based on the data from Launch-HTN and Advance-HTN trials, if lorundrostat [Technical Difficulty] is approved, they would likely prescribe it broadly for patients with uncontrolled or resistant hypertension, specifically third line or later.

This intent to prescribe was based on the differentiated efficacy and safety profile, which truly set lorundrostat apart from agents typically used in the third line or later treatment position. We’ve also completed a project with IQVIA that showed nearly 9 million patients in 2024 started new treatments in the third line or later position. These data are reflective of the dissatisfaction in the market and the challenges physicians face in addressing uncontrolled hypertension. Both of these data sets [Technical Difficulty] speak to the strong need and demand for innovative solutions that physicians want in their treatment armamentarium to address uncontrolled and resistant hypertension. Uncontrolled and resistant hypertension are significant unmet medical needs, impacting more than 20 million patients in the United States and directly contributing to adverse cardiorenal risk.

Our clinical results reinforce the differentiated clinical impact of targeting aldosterone with an ASI like lorundrostat as compared to the current standard of care used in third and fourth-line treatment physicians. We are continuing to focus our pre-commercial efforts on market access and payer value assessment for this novel treatment. We have expanded our medical communications team to disseminate the data we’re developing on lorundrostat via publications, medical conferences and field-based medical science liaisons [Technical Difficulty] prelaunch readiness to generate awareness, interest and enthusiasm for lorundrostat. I would now like to briefly touch on the other development activities we’re pursuing to enhance and extend the lorundrostat profile in hypertension with comorbid conditions, which are largely driven by inadequately controlled blood pressure and dysregulated aldosterone.

Our focus on and rationale behind making reduction in blood pressure, the primary outcome measure in the Explore-CKD trial was the central role of uncontrolled blood pressure in chronic kidney disease progression. Lorundrostat demonstrated a clinically meaningful reduction on systolic blood pressure in this trial. The key secondary outcome measure of reduction of UACR, an accepted surrogate for renal protection was also highly significant and comparable in magnitude to that observed in trials of lorundrostat and finerenone when combined with an SGLT2 inhibitor. It should be noted that all participants in Explore-CKD [Technical Difficulty] were treated with lorundrostat while on a stable therapeutic dose of SGLT2 inhibitor, most commonly dapagliflozin.

Immediately after the release of these data, First World Pharma surveyed 133 health care professionals and confirmed that these data were clinically meaningful, with 77% of the surveyed health care professionals indicating they would consider prescribing lorundrostat to CKD patients uncontrolled on either ACE inhibitor or ARB with an SGLT2 inhibitor. The rationale for our EXPLORE-OSA trial relates to the substantial portion of patients with obesity and resistant hypertension who also have OSA, [Technical Difficulty] which is often undiagnosed and untreated. A majority of OSA patients have uncontrolled or resistant hypertension as well as elevated nighttime blood pressure and hypoxia, which are drivers of major adverse cardiovascular events, including death.

Prior small studies of mineral corticoid receptor antagonist or adrenalectomy patients demonstrated an approximate 50% reduction in AHI, which is the primary registration endpoint. EXPLORE-OSA is powered for the AHI [Technical Difficulty] both 24-hour ABPM as well as a novel measurement of continuous blood pressure. We have clearly demonstrated that lorundrostat dosed once daily in the morning is a highly effective antihypertensive. Given the contribution of nighttime aldosterone production in OSA patients, the EXPLORE-OSA trial will be evaluating lorundrostat dosing at night, the effects on nighttime blood pressure and 24-hour blood pressure control. Based on the rate of enrollment in EXPLORE-OSA, we anticipate having top line data in the first [Technical Difficulty].

The next step in providing lorundrostat to the millions of patients who could benefit from its clinical profile is its regulatory approval. We have a pre-NDA meeting with the FDA scheduled to take place in the fourth quarter of 2025. In summary, we have now demonstrated the clinically meaningful benefit risk profile of lorundrostat in individuals with uncontrolled or resistant hypertension in four clinical trials. We continue to evaluate lorundrostat’s use in prevalent comorbidities of hypertension such as OSA in CKD, for which normalizing aldosterone production may result in meaningful clinical benefit. I will now turn the call over to Adam to review our financial results for the second quarter of 2025.

Adam Scott Levy: Thank you, Jon. Good afternoon, everyone. Today, I will discuss select portions of our second quarter 2025 financial results. Additional details can be found in our Form 10-Q, which will be filed with the SEC later today, August 12. We ended the quarter with cash, cash equivalents and investments of $324.9 million as of June 30, 2025, compared to $198.2 million as of December 31, 2024. We believe that our current cash, cash equivalents and investments will be sufficient to fund our planned clinical trials and regulatory activities as well as support corporate operations into 2027. R&D expenses for the quarter ended June 30, 2025, were $38.3 million compared to $39.3 million for the quarter ended June 30, 2024.

The decrease in R&D expenses was primarily due to a decrease of $4.5 million in preclinical and clinical costs driven by the conclusion of the lorundrostat pivotal program in the second quarter of 2025, partially offset by increases of $2.7 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation and $0.8 million in higher clinical supply and manufacturing, regulatory and other costs. G&A expenses were $8.5 million for the quarter ended June 30, 2025, compared to $5.9 million for the quarter ended June 30, 2024. The increase in G&A expenses was primarily due to $1.9 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation, $0.6 million in higher professional fees and $0.1 million in other administrative expenses.

Total other income net was $3.5 million for the quarter ended June 30, 2025, compared to $4.2 million for the quarter ended June 30, 2024. [Technical Difficulty] The decrease was primarily attributable to decreased interest earned on investments in money market funds and U.S. treasuries as a result of lower average cash balance invested during the 3 months ended June 30, 2025. Net loss was $43.3 million for the quarter ended June 30, 2025, compared to $41 million for the quarter ended June 30, 2024. The increase was primarily attributable to the factors impacting the company’s expenses described earlier. With that, I’ll ask the operator to open the call for questions. Operator?

Q&A Session

Operator: [Operator Instructions] And our first question comes from the line of Michael DiFiore with Evercore.

Michael DiFiore: On all the progress. Two for me. One question that we get a lot recently is AstraZeneca’s full Phase III BAX-HTM data that will be coming up later at ESC shortly. My question is, any thoughts on how different Grade 1 and Grade 2 hyperkalemia rates would need to be in order for physicians to consider lorundrostat more or less safe? And my follow-up question is, too, it’s separate. If there’s any — if there’s been any updates on partnership discussions and initiatives.

Jon Congleton: Yes, Mike, thanks for the call. I appreciate it. To your first question, it’s tough for me to opine on what AZ’s data may look like, what that may translate to from a potassium level and differentiation. We feel very confident in the package that we’ve developed over the last 4.5 years and certainly just in the last six months with the readout of Launch-HTN, Advance-HTN and ExPlore-CKD. I think we’ve very well characterized the efficacy of this drug and the safety of this drug in a spectrum of patients, and that was by design. Launch-HTN, I think, is the perfect trial to really look at where this drug are going to be used in the vast majority of patients on top of an existing background treatment that while not optimized is how physicians in the real world [Technical Difficulty] we saw an 11.7 — 11.6 millimeter mercury placebo-adjusted change, 19-millimeter absolute — and frankly, ACE inhibitor ARB level rates of hyperkalemia above 6 millimoles per liter of 0.6% of the patients.

So very well characterized, really robust clinical benefit, coupled with a very favorable safety profile that I know you’ve seen the survey that we’ve done that I referenced in the prepared remarks, 95% of physicians deem it as likely or very likely to prescribe if they get access to it if the drug gets approved. And so, it’s — we’ll have to see the data, Mike, from BAX-H10 because there’s so many things that go into that. What are the patient demographics, how are they measuring potassium, what’s confirmed, what’s observed just we need to get to the data. It’s a fair question, but it’s hard to opine on. As far as partnering dialogues, as we’ve alluded to in the past, we’re very interested in partnering, certainly ex U.S. where we don’t have intention of commercializing lorundrostat on our own, but even in the United States.

And the intent in the United States is how can [Technical Difficulty] we extend the reach to as many physicians to impact as many patients as possible that we think ultimately can maximize the value of lorundrostat, which we think can be significant in the management of uncontrolled and resistant hypertension.

Operator: Our next question comes from the line of Rich Law with Goldman Sachs.

Richard J. Law: The first is that when you think about lorundrostat outside hypertension, do you see any opportunity for lorundrostat to combine with other drugs besides SGLT2 inhibitors in CKD? And then I have a follow-up. Rich, are you saying specific to CKD?

Jon Congleton: No, just anything outside hypertension and maybe outside like SGLT2.

Richard J. Law: Is there any other disease areas or indications that you see potential combination strategy with lorundrostat?

Jon Congleton: Yes. I think the — what we’ve seen to date with 4 successful trials is that aldosterone in and of itself is a significant driver, not only of hypertension, but the related comorbidities, right? We know hypertension drives CKD. We know it drives heart failure. We know it drives and is a component of OSA. And in the 4 studies that we’ve done, we’re seeing robust response. If you think about it relative to just for hypertension, what other agents like alpha blockers, beta blockers, renal denervation, endothelin receptor antagonist, you’re seeing really compelling clinical benefit with lorundrostat, which I think speaks to the molecule, but it also speaks to the unmet need in dysregulated aldosterone. I think that extends by definition into these related comorbidities.

So hypertension and CKD, hypertension and OSA. I think given the small molecule nature of lorundrostat, there are some interesting fixed-dose combinations that we’ve contemplated. I can’t really get into that at this point in time. But I would say that fixed-dose combinations, their acceptance is varied by region. I think in Europe; you tend to see an inclination to use fixed-dose combinations more frequently than in the United States. I think in the United States; there’s actually more of an inclination to keep drugs as separate treatments to allow physicians to manage dose. And I think that’s where it becomes interesting, Rich, specifically to CKD, the dynamics that will be occurring with the SGLT2 market over the next several years with the introduction of likely generics.

with SGLT2s quickly becoming standard of care in the treatment of CKD and with the potential launch timing of lorundrostat for hypertension and with the data that we’ve collected to date in hypertension and CKD, there may not be a need for a fixed-dose combination to meet the needs of the patients with lorundrostat being able to address the aldosterone aspect of the condition. And as has been seen quickly adoption of the SGLT2 as standard of care in that population.

Richard J. Law: Okay. Got it. And then — so going back to your previous discussion on the BAX data at ESC, under what scenarios would you think that readout could negatively affect your discussions with potential partners or the outlook for lorundrostat? And also, do you think that most partners that you’ve been talking to see both of these drugs to be likely similar because they have the same MOA? Or do you think that they’re looking for like a best-in-class drug over the other?

Jon Congleton: Yes. Again, it’s hard to opine on what may be seen with the baxdrostat data. I’ll go to what we do know. And we know at this point, four successful trials are very well characterized and beneficial clinical profile with lorundrostat that based on the unmet need in the marketplace, I think, stands to generate significant value for patients and commercial value for shareholders. And so that’s what we’re focused on. As to the placement of or the availability of two ASIs. I think we’ve always said there’s certainly room for two within this marketplace. [Technical Difficulty] has a distinct offering as it relates to its selectivity and its half-life and the spectrum of data we’ve generated within the clinical development program. But with 20 million patients failing to get to go on two or more meds, we think there is significant opportunity for more than just one player in this space.

Richard J. Law: Got it. That makes sense. But I mean any comment on potential partners looking — I mean seeing these drugs to be similar versus there could be a best-in-class or there’s no such a thing?

Jon Congleton: It’s hard to get into specifics on that, Rich, but we remain confident in the value of lorundrostat.

Operator: Our next question comes from the line of Seamus Fernandez with Guggenheim Partners.

Seamus Christopher Fernandez: So a couple of quick ones here. Just in terms of drug-drug interactions and anything that could impact an outside assessment of lorundrostat, would you guys maybe just help us understand the cited PPI drug-drug interaction that you called out in your 2023 10- K.I think this is a very minor issue, but just wanted to confirm some of the details that you have around the PPI utilization in your trials as well as just kind of what your market research shows in terms of the frequency of use there, if there are any limitations at all? And then the second question really comes down to the sort of 24-hour profile. One of the things that AstraZeneca does cite is the prospect of potentially being differentiated in terms of the half-life. Just interested to know how you guys think about the profile of lorundrostat from a 24-hour perspective and what you might be hoping to see in your OSA study as well as those data emerge later this year.

Jon Congleton: Great. Thanks, Seamus. [Technical Difficulty] the first part of the question, the PPI, from the research that we’ve done, PPI use is in about 10% of adults, maybe about 15% in older adults. For both our launch and Advance-HTN study, we allowed PPI use three times per week. We recommended if people [Technical Difficulty] an H2 antagonist dosed in the evening, whereas lorundrostat was dosed in the morning. The reason for that is lorundrostat is the basic salt requires a level of acidity for full bioavailability. So, the question is not one, Seamus, of safety. It’s about exposure and ensuring coverage of that patient’s blood pressure. Now as you’re aware, the 50 milligram is the intended target starting dose. We have shown in Explore-CKD the 25 milligrams is active.

From the Explore-CKD, we saw about a 7.5-millimeter mercury placebo-adjusted change at 4 weeks. And so, we believe the 25-milligram is clearly an active dose. And so, if somebody is on 50, they have to be on a chronic PPI, we would just suggest that the physician monitor their blood pressure [Technical Difficulty] But again, within the two pivotal studies, we allowed periodic use of that and clearly saw robust clinical benefit. To your second question about 24-hour profile, I’ve heard that before. I would say after 4 clinical studies where we measure the in- office blood pressure the same way, and that is in the morning at trough before that day’s dose, we’re very confident in the 24-hour blood pressure control that we provide for patients.

So, looking at LaunchH10 with 11.6 millimeter mercury placebo-adjusted change, 19 absolute to advance that had almost 8-millimeter mercury placebo adjusted and 15.5 millimeter mercury absolute. Those were all done in the morning. The advance was the 24 hour. So, we clearly see that. And the numbers that I explained for ExPloOreE-CKD, the same thing, morning measurement at trough. So, we’re very confident in the 24-hour control.

Seamus Christopher Fernandez: And just a question on OSA, timing for OSA and what you might be hoping to see in that data set?

Jon Congleton: Yes. The — as we said — and sorry for missing that. As we said in the prepared remarks, there are interesting, albeit small studies that show with a mineral corticoid receptor antagonist or a unilateral adrenalectomy that you see improvement of AHI, frankly, in that 50% reduction of event range. [Technical Difficulty] current treatments like GLP-1s and CPAP do as effectively as the patients require. And so that’s why we’re doing the study right now. That’s why AHI is the primary endpoint, which is the registrational endpoint that could inform further clinical development for the program. As far as opining on what the blood pressure reduction will be, it’s hard to say. The nighttime dosing, as I said in the prepared remarks, is intended to really target the aldosterone surge that we believe is related to those OSA symptoms during the evening hour. And so, we’re really trying to match lorundrostat to the time of production of more aldosterone.

Operator: Our next question comes from the line of Tim Anderson with Bank of America.

Alice Jennifer Nettleton: This is Alice on for Tim. A question — first question is, what percentage of payers do you foresee putting in a step edit, i.e., requiring patients to [Technical Difficulty] And then the second question is, if there has been any apprehension by potential partners to partner with you, what are the things that they would like more clarity on? Or what is the biggest debate?

Unidentified Company Representative: Yes, Alice, thank you for your questions. Let me take the second one, and I’ll turn it over to Eric for your first one. As to any dialogues with prospective partners, we really haven’t gotten into specifics on that. Again, I’ll just pivot to the unmet need within this space, which we think is significant. coupled with the clinical profile that we’ve developed with the four studies to date that we think can be significant as far as addressing that unmet need. As regards to the payers, I’ll let Eric provide.

Eric Warren: Sure. Alex, thanks for the question. So, we do not anticipate a step through spironolactone. In fact, that’s something that we specifically asked payers during market research. The reason that they don’t — or they won’t put us through spiironolactone is a — about a 2% share in the hypertensive market for [Technical Difficulty] the payers recognize. Instead, what’s likely to happen is the payers will step us through 2 generic classes, which then creates an electronic step edit, which is easily navigatable through the cloud. So that’s our ultimate goal is to make sure that utilization management criteria are relatively modest, prescriber-friendly and that we ultimately optimize the net price.

Operator: Our next question comes from the line of Annabel Samimy with Stifel.

Jayed Momin: This is Jayed on for Annabel. So, we’ve got a couple. The first one is around — you guys are shifting into a commercial [Technical Difficulty] Who is going to be the initial target audience? And how will you stage the launch given the size of the company and what kind of reach you can have?

Jon Congleton: Yes. I’ll go ahead and take that question. I think it’s too early to get into the commercial strategy, staging, targeting. As I noted in the prepared remarks, I think the big focus right now is really on two vectors. One is just the payer strategy, and the value proposition based on the clinical data that we’ve generated to date. And then the second is really using medical affairs to ensure that we’re disseminating the data that we’ve generated to date through conferences, [Technical Difficulty]

Jayed Momin: And I’ve got one more here. How are you preparing for the pre-NDA meeting with the FDA? You’ve been pretty collaborative with the Cleveland Clinic and you also had a lot of comprehensive data in your clinical trials. What expectations do you have coming to the meeting? What kind of questions do you expect the FDA might have?

Jon Congleton: No, we’re confident [Technical Difficulty] it goes back to the end of Phase II meeting where we [Technical Difficulty] intended clinical development program, the purpose behind that as well as, as you’re well aware, all the other elements from CMC to nonclinical. So, we’re confident in the package that we put together and the comprehensive nature of it. I think the intent for the FDA when they review any new drug, is it well characterized across distinct populations. And we believe with Launch-HTN being existing background, Advance-HTN being truly optimized and [Technical Difficulty] CKD looking at subjects with hypertension, lower eGFR that we have a fairly comprehensive package going into those discussions with the FDA.

Jayed Momin: Great. I’m sorry, I do have one more quick one. Just regarding baxdrostat. I know their data hasn’t been published, but they did reach their goal. Is there — can you talk to us about any kind of counter detailing messaging that may be starting?

Jon Congleton: No. I think we’ll wait and see what their study shows, what the data shows [Technical Difficulty] unaddressed target right now in the treatment of not only hypertension but related comorbidities. We would anticipate see positive data, as they’ve alluded to, what that data is going to be as far as the magnitude of effect, the safety profile. I just — I think it’s far, far too early for us to even [Technical Difficulty] measurements before we could begin to [indiscernible] their data relative to ours, which is always a challenge across trials.

Operator: Our next question comes from the line of Rami Katkhuda with LifeSci Capital.

Rami Azeez Katkhuda: Two quick ones for me. First, has AstraZeneca noted whether they’re taking the average of 3 blood pressure readings similar to the SynCor Phase II studies? Or are they taking a similar approach to what you guys did in launch in advance? And I guess, how could that influence placebo response rates at the end of the day?

Jon Congleton: Yes. Rami, I don’t — the only thing I know [Technical Difficulty] what they’re doing with those measurements. As you’re aware [Technical Difficulty] with those automated devices. [Technical Difficulty] standpoint, that practice has paid off as far as helping us control the noise of placebo. I’m not sure what kind of strategies or operational plans that AZ has put in place to try to manage the placebo noise that was a bit of an issue with previous baxdrostat trials, specifically HALO.

Rami Azeez Katkhuda: Got it. And then I know it’s a bit of a race to become the first ASI in [Technical Difficulty] with lorundrostat before you can ultimately file an NDA?

Jon Congleton: No, they don’t give specific guidance to that, Rami. It’s in consultation with the consultants, [Technical Difficulty] helping us with this. It’s just making sure that we have what we feel to be an appropriate amount of the safety data for the FDA to begin their review and then not overload that submission with a 120-day safety update.

Operator: Our next question comes from the line of Mohit Bansal with Wells Fargo.

Sadia Rahman: This is Sadia Rahman on for Mohit. For ahead of the baxdrostat data, any trial design differences that you’d highlight for launch compared with Bax-HTN that could contribute to differences in either the efficacy or on the safety side? And would you expect differences on hyperkalemia rates to be driven more by trial design aspects or by pharmacokinetics of these drugs, [Technical Difficulty]

Jon Congleton: Yes. I think the as the Bax-HTN data becomes available, I think if you think about the breadth of our program, the most comparable study is probably Launch-HTN. The commonalities are both studies are looking at subjects failing to get to goal on two or more meds. It’s using in-office blood pressure measurement. [Technical Difficulty] But beyond that, it’s hard to opine on what else they may be doing within that study. And to your secondary question, how that may or may not impact from a design standpoint, rates of hyperkalemia, again, it depends upon how they characterize it, how they capture it, [Technical Difficulty] so it’s just difficult from a design standpoint for me to give a view on that. The pharmacokinetics, specifically the selectivity in the half-life, we know is distinct from lorundrostat.

[Technical Difficulty] cortisol. The half-life of 10 to 12 hours, we believe is kind of ideal, mirroring the diurnal nature of elevated aldosterone, theirs is 25 to 30 hours. It will be interesting, and I think that’s one of the things that we’re interested to see is just how does that all translate into their clinical profile. But it’s hard to opine ahead of actually seeing the data.

Sadia Rahman: Got it. And then regarding the open-label extension trial, do you plan to release more data from — or any data from that trial later this year? And can you talk about the potassium [Technical Difficulty] hyperkalemia we can see?

Jon Congleton: Yes. To broadly answer your question, we’re excited about the data we’re capturing within [indiscernible] of the open-label extension. That study will provide not only a longer-term view of efficacy and safety. But within that, we also have our randomized treatment withdrawal study, which is part of the NDA submission as well. We do plan on continuing to publish data out of that — both of [indiscernible upon conference schedule as well as publication, but we certainly do plan on getting that data out in the public in due course.

Operator: Our next question comes from the line of Matthew Caulfield with H.C. Wainwright.

Matthew Coleman Caufield: Great to see the success. So, I think KOL takeaways for lorundrostat safety have been that the serum potassium is to be expected, it can be managed, and it’s not expected to add to accruing levels over time. Could you foresee any reason the agency could be more scrutinizing of the serum potassium safety assessment as we head into the pre-NDA meeting in fourth quarter?

Jon Congleton: No, Matt, thanks for the call. The — again, I think it’s why it was important that we built the program the way we did, the way that Dave designed it was to really give us a sense for lorundrostat’s profile across the spectrum of patients. And so, I think that’s something the FDA actually will value and appreciate that we’ve characterized not only the clinical benefit, but also the safety profile in an existing kind of real-world population and an optimized treated population in a population with CKD and proteinuria. And so, we’re very confident with the package that we have right now to go to the FDA to characterize lorundrostat’s profile in some of these distinct populations.

Operator: Our next question comes from the line of Dennis Ding with Jefferies.

Yuchen Ding: [Technical Difficulty]between both ASIs, which I think is generally a consensus view. Is it size of the sales force duration of relationships with doctors? Is it magnitude of rebating? Like I guess, what specific factors will you be hyper focused on [Technical Difficulty] And then my second question is just around R&D synergy for an ASI. I mean, I guess CKD and heart failure are obvious, but what other indications do you think an ASI could add incremental value to on top of standard of care? And I presume that’s something [Technical Difficulty] of lorundrostat.

Jon Congleton: Yes. Dennis, thanks for the question. So, the first one, I think what we’re looking broadly at within a partner is how we can maximize reach to both prescribers and patients. If we look at how we’ve developed this molecule to date, it’s been with a pretty keen eye towards the commercial marketplace, realizing that it’s highly genericized, knowing that going first line would probably have significant barriers. But as you heard Eric opine later or earlier on, in that third-line position with proper pricing and rebate strategy, we believe that access is very manageable. And the reason for that is the significant unmet need there. Now that prescribing is driven to a fairly large degree, and we note this in our corporate deck by about 47,000 to 50,000 doctors in those top five deciles of third line or later prescribing.

And that’s a mix of cardiologists and primary care. So as we think about partnering, we factor that into that consideration. [Technical Difficulty], relationships, those are all informative to how we think about a partner. To your second question as far as the increment of an ASI and other categories, I don’t know that I could share with you all of the different areas that we thought about. You highlighted certainly 2 CKD and heart failure. From our standpoint, hypertension is a massive overlap with all of those. And that’s why we’ve framed our program the way we have. It’s why we think the Explore CKD program is so interesting and exciting because it allows us to operate within those patients that have an overlap and the ability to actively promote lorundrostat for patients who have hypertension as well as comorbid CKD.

And we know that there could be a dual benefit on reduction of UACR, which is a known surrogate for renal protection. But it’s also why we’re so excited about OSA. As I said in the prepared remarks, there’s significant overlap between not only resistant but uncontrolled hypertension and OSA. And there’s good evidence that shows targeting aldosterone will not only be a benefit for the blood pressure, but also for the symptoms of OSA. At this stage, I think we’re very comfortable in the profile of this drug as far as what it does to aldosterone, what it does to hypertension, how it does so safely, [Technical Difficulty] comorbidities. And so that’s something we’ll continue to evaluate as we think about further development of lorundrostat.

Yuchen Ding: Got it. And I had a quick follow-up. I think [Technical Difficulty] will be used and where your better selectivity could eventually come out positive. So, are you considering going after that indication? And why or why not?

Jon Congleton: Yes. Thanks, Dennis. I think I would put PA into some of the other categories. It’s certainly something we’re contemplating. Clearly, that’s probably the extreme edge of hypertension with aldosterone as a driver for that. [Technical Difficulty]as we look at all the different options that are out there.

Operator: And we have reached the end of the question-and-answer session. I would like to turn the floor back over to CEO, Jon Congleton, for closing remarks.

Jon Congleton: Thank you, operator. I appreciate everybody’s attention today. We believe the strength of the clinical results for lorundrostat showed the potential benefit for uncontrolled and resistant hypertension and those related comorbidities such as CKD and OSA we discussed today. We do look forward to our upcoming pre-NDA meeting with the FDA later this year. This is an exciting time for our team. [Technical Difficulty] with lorundrostat, the physicians and researchers that have worked so hard in support of bringing lorundrostat through our pivotal program and most [Technical Difficulty] We’re excited for key upcoming milestones and look forward to sharing updates with you in the upcoming quarters. With that said, I’ll say thank you, operator, and thank you to everyone for joining us today. With that, we’ll close the call.

Operator: Thank you. And ladies and gentlemen. [Technical Difficulty].